U.S. patent application number 10/762387 was filed with the patent office on 2005-07-21 for apparatus and methods for documenting myocardial ischemia.
Invention is credited to Hampton, David, Pearce, Christopher.
Application Number | 20050159666 10/762387 |
Document ID | / |
Family ID | 34750357 |
Filed Date | 2005-07-21 |
United States Patent
Application |
20050159666 |
Kind Code |
A1 |
Pearce, Christopher ; et
al. |
July 21, 2005 |
Apparatus and methods for documenting myocardial ischemia
Abstract
Methods and apparatus are provided for documenting the
myocardial ischemia of a patient's heart. The apparatus comprises
an ECG monitor and data collector configured to receive
electrocardial data about the patient's heart. The apparatus
further comprises a cardiac marker data collector configured to
receive cardiac marker data about the patient's heart. A data
processing and recording module is in electrical communication with
the ECG monitor and data collector and the cardiac marker data
collector and is configured to record the electrocardial data and
the cardiac marker data. The method comprises the steps of
obtaining electrocardial data about the patient's heart and
receiving results of a cardiac marker test performed on the
patient. The electrocardial data and the test results are stored in
a patient report, which then may be displayed.
Inventors: |
Pearce, Christopher;
(Monroe, WA) ; Hampton, David; (Woodinville,
WA) |
Correspondence
Address: |
INGRASSIA FISHER & LORENZ, P.C.
7150 E. CAMELBACK, STE. 325
SCOTTSDALE
AZ
85251
US
|
Family ID: |
34750357 |
Appl. No.: |
10/762387 |
Filed: |
January 21, 2004 |
Current U.S.
Class: |
600/509 |
Current CPC
Class: |
A61B 5/021 20130101;
A61B 5/0836 20130101; A61B 5/145 20130101; A61B 5/318 20210101 |
Class at
Publication: |
600/509 |
International
Class: |
A61B 005/0402 |
Claims
What is claimed is:
1. An apparatus for documenting the myocardial ischemia of a
patient's heart, the apparatus comprising: an ECG monitor and data
collector configured to receive electrocardial data about the
patient's heart; a cardiac marker data collector configured to
receive cardiac marker data about the patient's heart; and a data
processing and recording module in electrical communication with
said ECG monitor and data collector and said cardiac marker data
collector and configured to record said electrocardial data and
said cardiac marker data.
2. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 1, said data processing and recording
module comprising at least one of a processor and a memory
device.
3. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 1, wherein the apparatus further comprises
an user interface configured to permit entry of said cardiac marker
data for receipt by said cardiac marker data collector.
4. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 1, wherein said data processing and
recording module is configured to diagnose myocardial ischemia
based on said electrocardial data.
5. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 4, wherein said data processing and
recording module is configured to diagnose myocardial ischemia
based on said electrocardial data and said cardiac marker data.
6. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 5, wherein said data processing and
recording module is configured to suggest a treatment for
myocardial ischemia based on said electrocardial data and said
cardiac marker data.
7. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 1, the apparatus further comprising a
display module in electrical communication with said data
processing and recording module and configured to display at least
one of said electrocardial data and said cardiac marker data.
8. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 7, wherein said data processing and
recording module is configured to suggest a treatment for
myocardial ischemia based on said electrocardial data and said
cardiac marker data and said display module is configured to
display said suggested treatment.
9. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 7, said display module comprising at least
one of a visual display and a printer.
10. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 1, the apparatus further comprising an
interpretive ECG algorithm module in electrical communication with
said data processing and recording module.
11. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 1, wherein said data processing and
recording module is configured to detect a change over time of said
electrocardial data.
12. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 1, wherein said data processing and
recording module is configured to detect a change over time of said
electrocardial data and said cardiac marker data.
13. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 1, wherein said cardiac marker data
collector is configured to identify a time and a date of receipt of
said cardiac marker data.
14. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 1, wherein said data processing and
recording module is configured to generate a prompt to a user of
the apparatus to perform a cardiac marker test.
15. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 14, wherein said prompt comprises at least
one of a visual signal and an auditory signal.
16. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 1, wherein said data processing and
recording module is configured to monitor a time period for
performing a cardiac marker test on the patient and to generate a
request for results of said cardiac marker test when said time
period has expired.
17. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 1, the apparatus further comprising a
patient data collector that is in electrical communication with
said data processing and recording module and is configured to
receive patient data comprising at least one of a name of the
patient, an identification number of the patient, an age of the
patient, a sex of the patient, and a race of the patient.
18. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 17, wherein the apparatus further
comprises a user interface configured to permit entry of said
patient data for receipt by said patient data collector.
19. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 1, the apparatus further comprising at
least one patient parameter monitor and collector that is in
electrical communication with said data processing and recording
module and that is configured to receive data regarding a
physiological state of the patient.
20. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 19, wherein said data regarding a
physiological state of the patient comprises at least one of a
heart rate of the patient, a blood pressure of the patient, a
hemoglobin oxygen saturation of the patient, and an end-tidal
carbon dioxide of the patient.
21. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 1, the apparatus further comprising a
housing enclosing said ECG monitor and data collector, said cardiac
marker data collector and said data processing and recording
module.
22. A method for documenting the myocardial ischemia of a patient's
heart, the method comprising: obtaining electrocardial data about
the patient's heart; receiving results of a cardiac marker test
performed on the patient; storing said electrocardial data and said
results of said cardiac marker test in a patient report; and
displaying said patient report.
23. The method for documenting the myocardial ischemia of a
patient's heart of claim 22, the step of displaying said patient
report comprising displaying said patient report on a visual
display.
24. The method for documenting the myocardial ischemia of a
patient's heart of claim 22, the step of displaying said patient
report comprising printing said patient report.
25. The method for documenting the myocardial ischemia of a
patient's heart of claim 22, the method further comprising the step
of identifying a time and a date of receipt of said cardiac marker
data and storing said time and said date in said patient
report.
26. The method for documenting the myocardial ischemia of a
patient's heart of claim 22, the method further comprising the step
of obtaining data regarding the physiological state of the
patient.
27. The method for documenting the myocardial ischemia of a
patient's heart of claim 26, the step of obtaining data regarding
the physiological state of the patient comprising obtaining at
least one of a heart rate of the patient, a blood pressure of the
patient, a hemoglobin oxygen saturation of the patient and an
end-tidal carbon dioxide of the patient.
28. The method for documenting the myocardial ischemia of a
patient's heart of claim 26, the method further comprising the step
of storing said data regarding the physiological state of the
patient in said patient report.
29. The method for documenting the myocardial ischemia of a
patient's heart of claim 22, the method further comprising the step
of providing a prompt for the performance of a cardiac marker
test.
30. The method for documenting the myocardial ischemia of a
patient's heart of claim 22, the method further comprising the step
of analyzing said electrocardial data to determine if myocardial
ischemia is suggested by said electrocardial data.
31. The method for documenting the myocardial ischemia of a
patient's heart of claim 30, the method further comprising the step
of providing a notification that myocardial ischemia is diagnosed
in the patient if said electrocardial data suggests myocardial
ischemia.
32. The method for documenting the myocardial ischemia of a
patient's heart of claim 30, the method further comprising the step
of analyzing said electrocardial data to determine the severity of
myocardial ischemia of the patient's heart.
33. The method for documenting the myocardial ischemia of a
patient's heart of claim 30, the method further comprising the step
of providing a prompt for the performance of a cardiac marker test
if said electrocardial data suggests myocardial ischemia.
34. The method for documenting the myocardial ischemia of a
patient's heart of claim 30, the method further comprising the step
of analyzing said electrocardial data and said cardiac marker data
to determine if myocardial ischemia is suggested by said
electrocardial data and said cardiac marker data.
35. The method for documenting the myocardial ischemia of a
patient's heart of claim 22, the method further comprising the step
of analyzing said electrocardial data to detect a change over time
of said electrocardial data.
36. The method for documenting the myocardial ischemia of a
patient's heart of claim 22, the method further comprising the step
of analyzing said electrocardial data and said cardiac marker data
to detect a change over time of said electrocardial data and said
cardiac marker data.
37. The method for documenting the myocardial ischemia of a
patient's heart of claim 22, the method further comprising the
steps of monitoring a time period for performing a cardiac marker
test on the patient and generating a request for results of said
cardiac marker test when said time period has expired.
38. The method for documenting the myocardial ischemia of a
patient's heart of claim 22, the method further comprising the step
of receiving patient data comprising at least one of a name of the
patient, an identification number of the patient, an age of the
patient, a sex of the patient, and a race of the patient.
39. The method for documenting the myocardial ischemia of a
patient's heart of claim 38, the method further comprising the step
of storing said patient data in said patient report.
40. An apparatus for documenting the myocardial ischemia in a
patient's heart, the apparatus comprising: means for receiving
electrocardial data about the patient's heart; means for receiving
cardiac marker data about the patient's heart; means for processing
said electrocardial data and said cardiac marker data; means for
recording said electrocardial data and said cardiac marker data
into a patient record; and means for displaying said patient
record.
41. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 40, said means for processing said
electrocardial data and said cardiac marker data comprising a
processor.
42. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 40, said means for recording said
electrocardial data and said cardiac marker data comprising a
memory device.
43. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 40, wherein the apparatus further
comprises means for permitting entry of said cardiac marker data
for receipt by said cardiac marker data collector.
44. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 43, wherein said means for permitting
entry of said cardiac marker data comprises one of a keyboard, a
keypad and a touch screen.
45. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 40, wherein said means for processing said
electrocardial data and said cardiac marker data further comprises
means for diagnosing myocardial ischemia based on said
electrocardial data.
46. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 40, wherein said means for processing said
electrocardial data and said cardiac marker data further comprises
means for diagnosing myocardial ischemia based on said
electrocardial data and said cardiac marker data.
47. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 46, wherein said means for processing said
electrocardial data and said cardiac marker data further comprises
means for suggesting a treatment for myocardial ischemia.
48. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 47, wherein said means for displaying said
patient record further comprises means for displaying said
suggested treatment.
49. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 40, said means for displaying said patient
record comprises at least one of a visual display and a
printer.
50. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 40, the apparatus further comprising means
for interpreting said electrocardial data, said means for
interpreting said electrocardial data in electrical communication
with said means for processing said electrocardial data and said
cardiac marker data.
51. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 40, wherein said means for processing said
electrocardial data and said cardiac marker data comprises means
for detecting a change over time of said electrocardial data.
52. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 40, wherein said means for processing said
electrocardial data and said cardiac marker data comprises means
for detecting a change over time of said electrocardial data and
said cardiac marker data.
53. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 40, wherein said means for receiving
cardiac marker data comprises means for identifying a time and a
date of receipt of said cardiac marker data.
54. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 40, wherein said means for processing said
electrocardial data and said cardiac marker data comprises means
for generating a prompt to a user of the apparatus to perform a
cardiac marker test.
55. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 54, wherein said prompt comprises at least
one of a visual signal and an auditory signal.
56. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 40, wherein means for processing said
electrocardial data and said cardiac marker data comprise means for
monitoring a time period for performing a cardiac marker test on
the patient and means for generating a request for results of said
cardiac marker test when said time period has expired.
57. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 40, the apparatus further comprising means
for collecting patient data, wherein said means for collecting
patient data is in electrical communication with said means for
processing said electrocardial data and said cardiac marker data,
and wherein said means for collecting patient data comprises means
for receiving patient data comprising at least one of a name of the
patient, an identification number of the patient, an age of the
patient, a sex of the patient, and a race of the patient.
58. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 57, wherein the apparatus further
comprises means for permitting entry of said patient data for
receipt by said means for collecting patient data.
59. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 40, the apparatus further comprising at
least one means for collecting patient parameter data, wherein said
at least one means for collecting patient parameter data is in
electrical communication with said means for processing said
electrocardial data and said cardiac marker data, and wherein said
at least one means for collecting patient parameter data comprises
means for receiving data regarding a physiological state of the
patient.
60. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 59, wherein said data regarding a
physiological state of the patient comprises at least one of a
heart rate of the patient, a blood pressure of the patient, a
hemoglobin oxygen saturation of the patient and an end-tidal carbon
dioxide of the patient.
61. The apparatus for documenting the myocardial ischemia of a
patient's heart of claim 40, the apparatus further comprising a
housing enclosing at least a portion of said means for receiving
electrocardial data about the patient's heart, said means for
receiving cardiac marker data about the patient's heart and said
means for processing said electrocardial data and said cardiac
marker data.
62. A medical apparatus of the type that is configured to monitor
the electrocardiogram waveform of a patient, the medical apparatus
comprising: a cardiac marker data collector configured to receive
cardiac marker data about the patient's heart; a data processor in
electrical communication with said cardiac marker data collector; a
memory module in electrical communication with said data processor
and configured to record said electrocardiogram waveform and said
cardiac marker data; and a display module in electrical
communication with said data processor and configured to display at
least one of the electrocardiogram waveform and said cardiac marker
data.
63. The medical apparatus of claim 62, wherein the apparatus
further comprises a user interface configured to permit entry of
said cardiac marker data for receipt by said cardiac marker data
collector.
64. The medical apparatus of claim 62, wherein said data processor
is configured to diagnose myocardial ischemia based on the
electrocardiogram waveform and said cardiac marker data.
65. The medical apparatus of claim 62, wherein said data processor
is configured to diagnose myocardial ischemia based on the
electrocardiogram waveform.
66. The medical apparatus of claim 64, wherein said data processor
is configured to suggest a treatment for myocardial ischemia based
on the electrocardiogram waveform and said cardiac marker data.
67. The medical apparatus of claim 66, wherein said display module
is configured to display said suggested treatment.
68. The medical apparatus of claim 62, said display module
comprising at least one of a visual display and a printer.
69. The medical apparatus of claim 62, wherein said data processor
is configured to detect a change over time of said
electrocardiogram waveform.
70. The medical apparatus of claim 62, wherein said data processor
is configured to detect a change over time of said cardiac marker
data.
71. The medical apparatus of claim 62, wherein said cardiac marker
data collector is configured to identify a time and a date of
receipt of said cardiac marker data.
72. The medical apparatus of claim 62, wherein said data processor
is configured to generate a prompt to a user of the apparatus to
perform a cardiac marker test.
73. The medical apparatus of claim 72, wherein said prompt
comprises at least one of a visual signal and an auditory
signal.
74. The medical apparatus of claim 62, wherein said data processor
is configured to monitor a time period for performing a cardiac
marker test on the patient and to generate a request for results of
said cardiac marker test when said time period has expired.
75. The medical apparatus of claim 62, the medical apparatus
further comprising a patient data collector that is in electrical
communication with said data processor and is configured to receive
patient data comprising at least one of a name of the patient, an
identification number of the patient, an age of the patient, a sex
of the patient, and a race of the patient.
76. The medical apparatus of claim 75, wherein the medical
apparatus further comprises a user interface configured to permit
entry of said patient data for receipt by said patient data
collector.
77. The medical apparatus of claim 62, the apparatus further
comprising at least one patient parameter monitor and collector
that is in electrical communication with said data processor and
that is configured to receive data regarding a physiological state
of the patient.
78. The medical apparatus of claim 77, wherein said data regarding
a physiological state of the patient comprises at least one of a
heart rate of the patient, a blood pressure of the patient, a
hemoglobin oxygen saturation of the patient and an end-tidal carbon
dioxide of the patient.
79. The medical apparatus of claim 62, the apparatus further
comprising a housing enclosing at least a portion of said cardiac
marker data collector, at least a portion of said data processor
and at least a portion of said memory module.
Description
FIELD OF THE INVENTION
[0001] The present invention generally relates to medical devices
for monitoring cardiac episodes, and more particularly relates to
devices and techniques for documenting the presence of myocardial
ischemia in patients.
BACKGROUND OF THE INVENTION
[0002] Myocardial ischemia is the result of an imbalance between
myocardial oxygen supply and demand and is a reversible process if
blood flow is restored before cellular damage occurs. Ischemia can
result from increased myocardial oxygen demands or from decreased
myocardial oxygen supply. If ischemia is severe and blood flow is
not restored relatively soon, cellular injury and eventually
necrosis (infarction) result. Myocardial infarction can occur
because of blockage of a coronary artery with thrombus or from
severe and prolonged ischemia due to coronary artery spasm or
unrelieved obstruction of a coronary artery.
[0003] Angina pectoris (angina), literally "strangling of the
chest," is often a symptom of myocardial ischemia. Angina is
traditionally classified as "stable" or "unstable", depending upon
severity. Stable angina, the least alarming form of ischemia, is
caused by a high demand for oxygen by the myocardium during
exertion. It is characterized by transient episodes of substemal
chest pain or discomfort and is usually relieved by rest. Unstable
angina, which occurs when the patient is at rest or is not relieved
by rest, may be classified as intermediate in severity between
stable angina and myocardial infarction.
[0004] Electrocardiography (ECG) is a cost-effective test that is
widely available for the diagnosis of myocardial ischemia in
patients. Unequivocal ECG changes that indicate myocardial
infarction include the development of abnormal, persistent Q waves,
the presence of a QS complex in two or more leads, or an evolving
injury current pattern lasting longer than one day. The presence of
Q waves indicates infarcted tissue that extends at least halfway
through the myocardial wall.
[0005] However, ECG results do not always definitively indicate the
presence or absence of acute ischemia. For example, common patterns
of ischemia include T-wave inversion and ST segment elevation,
although T-wave inversion and ST segment elevation are often
non-specific findings and can be due to a variety of causes other
than ischemia, such as cardiomyopathies, pulmonary embolism,
pericarditis, and subarachnoid hemorrhage. Other equivocal ECG
changes that are not diagnostic but are suggestive of myocardial
infarction consist of an abnormal Q wave or conduction
disturbances. In addition, the diagnosis of acute myocardial
infarction becomes difficult or impossible when there are
preexisting ECG abnormalities such as left bundle-branch block, an
old myocardial infarction in the same area, ventricular
hypertrophy, and Wolff-Parkinson-White syndrome.
[0006] To confirm the presence of myocardial infarction suggested
by ECG results, other tests may be performed on the patient. For
example, certain serum markers rise in a patient after a myocardial
infarction. Creatine kinase (CK) and its iso-enzyme MB (CK-MB) are
enzymes released with tissue necrosis. Myoglobin, a heme protein,
is found in all striated tissue and is released from myocytes after
tissue injury. Troponin T or troponin I is released upon cardiac
necrosis. Thus, cardiac marker tests of a patient's blood to
determine the presence and levels of serum markers may facilitate
confirmation of myocardial infarction.
[0007] However, the various tests conducted to confirm myocardial
ischemia may be performed by a number of different technicians or
other emergency personnel using various medical equipment at
various locations. Accordingly, compilation of the information
necessary for a physician, a clinician or other medical personnel
to make an accurate and timely diagnosis of myocardial ischemia may
be difficult. Further, during an emergency response situation, when
a patient is experiencing painful angina, the performance of
certain tests that may facilitate diagnosis may be overlooked or
may be performed inaccurately.
[0008] Accordingly, it is desirable to provide an apparatus for
documenting and storing in one location various monitoring and test
results that may indicate myocardial ischemia in a patient's heart.
In addition, it is desirable to provide a method for documenting in
one location myocardial ischemia in a patient's heart. Furthermore,
other desirable features and characteristics of the present
invention will become apparent from the subsequent detailed
description of the invention and the appended claims, taken in
conjunction with the accompanying drawings and this background of
the invention.
BRIEF SUMMARY OF THE INVENTION
[0009] In accordance with an exemplary embodiment of the present
invention, there is provided an apparatus for documenting the
myocardial ischemia of a patient's heart. The apparatus comprises
an ECG monitor and data collector configured to receive
electrocardial data about the patient's heart. The apparatus
further comprises a cardiac marker data collector configured to
receive cardiac marker data about the patient's heart. A data
processing and recording module is in electrical communication with
the ECG monitor and data collector and the cardiac marker data
collector and is configured to record the electrocardial data and
the cardiac marker data.
[0010] In accordance with another exemplary embodiment of the
invention, there is provided a method for documenting the
myocardial ischemia of a patient's heart. The method comprises the
steps of obtaining electrocardial data about the patient's heart
and receiving results of a cardiac marker test performed on the
patient. The electrocardial data and the test results are stored in
a patient report, which then may be displayed.
[0011] In accordance with a further exemplary embodiment of the
invention, there is provided an apparatus for documenting the
myocardial ischemia of a patient's heart. The apparatus comprises
means for receiving electrocardial data about the patient's heart
and means for receiving cardiac marker data about the patient's
heart. The apparatus further comprises a means for processing the
electrocardial data and the cardiac marker data into a patient
record and means for displaying the patient record.
[0012] In yet another exemplary embodiment of the invention, there
is provided a medical apparatus of the type that is configured to
monitor the electrocardiogram waveform of a patient. The medical
apparatus comprises a cardiac marker data collector configured to
receive cardiac marker data about the patient's heart. The medical
apparatus also comprises a data processor in electrical
communication with the cardiac marker data collector. A memory
module is in electrical communication with the data processor and
is configured to record the electrocardiogram waveform and the
cardiac marker data. A display module is in electrical
communication with the data processor and is configured to display
at least one of the electrocardiogram waveform and the cardiac
marker data.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The present invention will hereinafter be described in
conjunction with the following drawing figures, wherein like
numerals denote like elements, and
[0014] FIG. 1 is a simplified schematic block diagram of an
apparatus for documenting myocardial ischemia of a patient's heart
in accordance with an exemplary embodiment of the present
invention;
[0015] FIG. 2 is schematic illustration of an apparatus for
documenting myocardial ischemia in accordance with an exemplary
embodiment of the present invention; and
[0016] FIG. 3 is a simplified flow chart of a process for
documenting myocardial ischemia of a patient's heart in accordance
with an exemplary embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0017] The following detailed description of the invention is
merely exemplary in nature and is not intended to limit the
invention or the application and uses of the invention.
Furthermore, there is no intention to be bound by any theory
presented in the preceding background of the invention or the
following detailed description of the invention.
[0018] According to various embodiments of the present invention,
an apparatus is configured to document the myocardial ischemia of a
patient's heart. The apparatus monitors and collects data regarding
the electrocardiogram of the patient's heart and also collects data
regarding the results of a cardiac marker test performed on the
patient. In other embodiments of the invention, the apparatus also
may monitor various other parameters of the patient's condition and
gather data regarding the patient and the patient's cardiac state.
The apparatus then may display the various data together to
facilitate the identification and/or treatment of myocardial
ischemia in the patient's heart. In this manner, data that will
facilitate the accurate and timely diagnosis of myocardial ischemia
may be generated, collected, and stored in one apparatus and may be
presented to a physician, clinician, technician or the like in a
comprehensive patient report.
[0019] FIG. 1 is a simplified schematic block diagram of an
apparatus 10 for documenting the myocardial ischemia of a patient's
heart, in accordance with one exemplary embodiment of the present
invention. Apparatus 10 suitably comprises an ECG monitor and data
collector module 12, a cardiac marker data collector module 22, a
processor module 14, and a patient data display module 24. Each of
the various modules may be implemented with computer-executable
instructions stored in a memory 18 and executed on processor module
14, or in any other manner.
[0020] ECG monitor and data collector module 12 is any circuit,
programming routine, application and/or other hardware/software
that permits suitable coupling of apparatus 10 to a patient 20 and
that generates electrical impulses or other observed signals that
can be used to model the patient's electrocardiogram ("PQRST")
waveform (hereinafter "ECG data"). ECG monitor and data collector
module 12 is in electrical communication with processor 14 and is
configured to transmit the ECG data to processor 14 for analysis
and/or storage. ECG monitor and data collector module 12 may
utilize any suitable ECG monitoring configuration but preferably
utilizes an industry standard 12-lead configuration. ECG monitor
and data collector module 12 may be coupled to patient 20 for
electrocardiogram monitoring using any suitable number of sensor
connections, such as 4-wire connections, 6-wire connections,
10-wire connections and the like. In addition to the ECG data, ECG
monitor and data collector module 12 may be configured to gather
data regarding the time and date of the ECG monitoring of a
patient.
[0021] In a further exemplary embodiment of the invention,
apparatus 10 may interpret the data collected by ECG monitor and
data collector module 12 to indicate or suggest to a user of
apparatus 10, or to a physician, or other clinician or technician,
that myocardial ischemia of the heart of patient 20 is or may be
present. In this embodiment of the invention, apparatus 10 may
comprise an interpretive ECG algorithm module 16, which may be any
circuit, programming routine and/or hardware/software that receives
ECG data from processor 14, analyzes the data, and sends an
interpretation of the data back to processor 14 for delivery to a
user or other person. Interpretive ECG algorithm 16 may utilize any
suitable algorithm that analyzes the ECG data collected by ECG
monitor and data collector 12 and interprets the data to determine
if myocardial ischemia is suggested by the data. Preferably,
interpretive ECG algorithm 16 comprises an industry-standard
interpretive 12-lead algorithm. Examples of suitable algorithms
include the GE Marquette 12SL ECG analysis program manufactured by
GE Medical Systems of Waukesha, Wis. and the Glasgow Royal
Infirmary Interpretive ECG algorithm developed by the University of
Glasgow of Glasgow, Scotland.
[0022] Processor 14 is any circuit, programming routine,
application or other hardware/software module that is capable of
processing data received from ECG monitor and data collector 12,
and any of the other various patient parameter monitors described
below, and causing such data to be displayed. Processor 14 may be
implemented with any type of microprocessor, digital signal
processor, application specific integrated circuit (ASIC) or other
integrated or discrete logic circuitry programmed or otherwise
configured to provide functionality as described herein. Processor
14 executes instructions stored in a digital memory 18 to provide
functionality as described below. Instructions provided to
processor 14 may be executed in any manner, using any data
structures, architecture, programming language and/or other
techniques. Digital memory 18 is any storage medium capable of
maintaining digital data and instructions provided to processor 14,
such as a static or dynamic random access memory (RAM), or any
other electronic, magnetic, optical or other storage medium.
[0023] Apparatus 10 further comprises a cardiac marker data
collector module 22, which is any circuit, programming routine,
application or other hardware/software module that is configured to
receive data regarding the results of a cardiac marker test
performed on the patient. Cardiac marker data collector module 22
may be coupled to processor 14 and is configured to transmit
cardiac marker test results data to processor 14. Processor 14 then
may transmit that data to memory 18 for storage and later retrieval
or may transmit the data for display, as described in more detail
below. Data may be received by cardiac marker data collector in any
suitable form. For example, data may be received as a "positive" or
"negative" election, that is, the data may indicate results
positively confirming cardiac marker elevation or may indicate no
cardiac maker elevation. Alternatively, the data may be received as
a numeric indication of the level of a cardiac marker(s) in the
patient's blood. Accordingly, any suitable cardiac marker test may
be performed on patient 20 and the results may be entered using
cardiac marker data collector 22. An example of a cardiac marker
test suitable for use with the present invention includes, but is
not limited to, the Cardiac Status.TM. point-of-care test kit
manufactured by Spectral Diagnostics, Inc. of Toronto, Ontario,
Canada. Cardiac marker data collector 22 may comprise any suitable
data input configuration, such as, for example, a keypad or touch
screen, used for entering cardiac marker test results into cardiac
marker data collector 22. In various embodiments of the invention,
cardiac marker data collector 22 also may be configured to identify
the time and date of entry of the cardiac marker test results. In
this manner, later confirmation that a cardiac marker test was
performed in accordance with a prescribed emergency protocol or
routine may be confirmed.
[0024] In one exemplary embodiment of the invention, processor 14
or other suitable component of apparatus 10 may be configured to
interpret the ECG data collected by ECG monitor and collector
module 12 in conjunction with cardiac marker test results collected
by cardiac marker data collector 22 to suggest or indicate to a
user of apparatus 10, or to a physician or other clinician or
technician, that myocardial ischemia is or may be present in the
heart of patient 20. In this manner, if interpretive ECG algorithm
16 is not able to confirm the presence of myocardial ischemia,
processor 14 may enhance the certainty with which apparatus 10 may
diagnose myocardial ischemia by assessing both the ECG data, and/or
the interpretation of the ECG data by interpretive ECG algorithm
16, and the results of the cardiac marker test. Once processor 14
has assessed the data, processor's 14 interpretation of the data
may be displayed to the user of apparatus 10 or any other
physician, clinician or technician via a patient data display
module 24, described in more detail below. In another embodiment of
the present invention, processor 14 may cause to be displayed a
suggested course of treatment or other action that is based on the
diagnosis.
[0025] Apparatus 10 also comprises a patient data display module
24, which comprises any circuit, programming routine, application
or hardware/software module that suitably displays data received
from processor 14, such as data collected by ECG monitor and
collector module 12 and cardiac marker data collector 22. Patient
data display 24 may comprise any display suitable for providing to
a user, technician, physician, clinician, or the like the ECG data
gathered by ECG monitor and data collector 12 and the cardiac
marker test results gathered by cardiac marker data collector 22.
In one exemplary embodiment of the invention, patient data display
24 may comprise a visual display, such as a liquid crystal display,
a CRT screen, a television screen, and the like. In another
exemplary embodiment of the invention, patient data display 24 may
comprise a printer that prints a patient report of any of the data
received from processor 14. In a further exemplary embodiment of
the invention, patient data display 24 may comprise both a visual
display and printer. In this manner, ECG data and cardiac marker
tests results may be displayed via a visual display to the user of
apparatus 10 and/or also may be stored in memory 18 for later
display in a printed patient report.
[0026] In another exemplary embodiment of the present invention,
apparatus 10 may be configured to provide instructions to a user to
conduct a cardiac marker test depending on the results of the ECG
data collected by ECG monitor and data collector 12 and interpreted
by interpretive ECG algorithm 16. For example, if interpretive ECG
algorithm 16 interprets the ECG data and concludes that the ECG
data may suggest myocardial ischemia but that such a determination
is not definitive, processor 14, which receives and processes data
received from interpretive ECG algorithm 16, may produce a prompt
instructing the user to perform a cardiac marker test. The prompt
may be provided as instructions appearing on a visual display, such
as patient data display 24, as a signal light appearing on
apparatus 10, or may be an alarm or other auditory signal, or any
other suitable prompt or signal. Alternatively, if interpretive ECG
algorithm 16 interprets the ECG data and concludes that the ECG
data indicates myocardial ischemia, processor 14 may be configured
so that a user is not provided a prompt to conduct a cardiac marker
test. In another embodiment of the invention, apparatus 10 may be
configured to provide instructions to a user to conduct a cardiac
marker test regardless of the ECG data or any interpretation
thereof.
[0027] In yet another exemplary embodiment of the present
invention, apparatus 10 may provide a prompt to the user to enter
cardiac marker test results into cardiac marker data collector 22
after a predetermined amount of time has elapsed from initiation of
the cardiac marker test. In this embodiment of the invention,
apparatus 10 may provide a prompt to a user to conduct a cardiac
marker test, as described above. The user then may be required to
indicate, via a keypad, a touch screen or other suitable device of
apparatus 10, the commencement of a cardiac marker test. Processor
14 receives data indicating the commencement of a cardiac marker
test and initiates operation of a clock 26 or other timing device.
Processor 14 then monitors clock 26 to determine if a preset period
of time has elapsed. When a preset period of time has elapsed,
processor 14 may provide an alarm, a visual prompt, or other
suitable notification to the user to enter the cardiac marker test
results into cardiac marker data collector 22. Apparatus 10 may
monitor a preprogrammed period of time for performance of a cardiac
marker test or, alternatively, apparatus 10 may be configured to
permit a user to program a desired time period for performance of a
cardiac marker test.
[0028] In another exemplary embodiment of the invention, processor
14 of apparatus 10 may be configured to monitor and compute the
change over time of the electrocardiogram waveform of patient 20
and/or the circulating levels of the cardiac markers in patient 20.
In this manner, a determination of mutually reinforcing changes in
the electrocardiogram waveform of patient 20 and the circulating
levels of the cardiac markers in patient 20 may be used to further
enhance diagnostic accuracy and to evaluate the effectiveness of
any therapies being provided to patient 20. For example, if
processor 14 detects a change in the electrocardiogram over a
preset period of time, apparatus 10 may prompt the user to perform
a cardiac marker test. If processor 14 determines that the results
of the cardiac marker test confirm the presence or absence of
myocardial ischemia, processor 14 may cause the diagnosis to be
displayed, such as via patient data display module 24. Processor 14
also may cause a suggested treatment to be displayed. In another
example, if processor 14 determines that concurrent changes in the
electrocardiogram waveform and in the cardiac marker test results
indicate that myocardial infarction is imminent, it may cause this
diagnosis to be displayed and/or cause a suggested treatment to be
displayed.
[0029] Apparatus 10 further may comprise a patient data collector
28, which is operably connected to processor 14. Patient data
collector 28 may receive identifying information of the patient and
other data that may facilitate the diagnosis of myocardial ischemia
of the patient's heart. Examples of patient data that may be
received by patient data collector 28 include the patient's name
and/or an identification number associated with the patient, the
patient's age, the patient's sex, the patient's race, and the like.
Patient data collector 28 may utilize any suitable data input
configuration, such as, for example, a keypad, keyboard, or touch
screen, used for entering patient data.
[0030] Apparatus 10 also may comprise one or more monitors and
collectors 30 of other physiological parameters of the patient that
may facilitate the diagnosis of myocardial ischemia in patient 20.
Monitor and collector(s) 30 may be suitably coupled to patient 20
to monitor and gather data relating to the physiological state of
patient 20 and may transmit the data to processor 14. Processor 14
then may cause the data to be stored in memory 18 and/or may cause
the data to be displayed via patient data display 24. Monitor and
collector(s) 30 may be suitably coupled to patient 20 to monitor
and collect data regarding any suitable parameter indicative of the
physiological state of patient 20, such as, for example, the heart
rate of patient 20, the oxygen saturation of the patient's 20
hemoglobin, the venous and/or arterial blood pressure of patient
20, and/or the end-tidal carbon dioxide of patient 20. Apparatus 10
may suitably display the data gathered by one monitor and collector
30 or, alternatively may display the data gathered by two or more
monitors and collectors 30.
[0031] It will be appreciated that the exemplary blocks shown in
FIG. 1 are intended to illustrate one logical model for
implementing an apparatus for documenting the myocardial ischemia
of a patient's heart. However, the model illustrated in FIG. 1
should not be construed as limiting. Indeed, the various practical
embodiments may have widely varying software modules, data
structures, applications, processes and the like. As such, the
various functions of each block or module of FIG. 1 may in practice
be combined, augmented, optimized or otherwise differently
organized in any fashion.
[0032] The various above-described components of apparatus 10 may
be housed in a common housing 200, such as that illustrated in FIG.
2. Housing 200 may comprise patient data display module 24 (FIG. 1)
that utilizes a visual display 202. Visual display 202 may be
configured to display the data collected by ECG monitor and
collection module 22 and cardiac marker data collector 22 (FIG. 1),
the patient data collected by patient data collector 28 (FIG. 1),
and/or the patient physiological parameters collected by monitor
and collector module(s) 30. Housing 200 also may comprise a user
interface 204, such as, for example, a keyboard, keypad, or a touch
screen, that is configured to receive from a user of apparatus 10
instructions or data, such as, for example, cardiac marker test
results and/or patient identification data. Housing 200 further may
comprise connectors 206 that are configured to receive sensor
connections (not shown), that suitably couple a patient to
apparatus 10, such as ECG lead wires, blood pressure monitors,
carbon dioxide monitors, and the like.
[0033] In an alternative embodiment of the invention, portions of
apparatus 10 may be housed separately from housing 200. For
example, where patient data display 24 comprises a printer for
printing out a patient report, the printer could be integrated with
apparatus 10 or provided in a separate housing. In this case,
processor 14 housed within housing 200 may interact with the
printer via an electrical cable or wireless link. Alternatively,
apparatus 10 may comprise a printer disposed at least partially
within housing 200 and a printer disposed remotely from housing
200. In another example, a visual display may be located remotely
from housing 200, such as in a hospital or doctor's office, and may
interact with processor 14 via an electrical cable or wireless
link. Alternatively, apparatus 10 may comprise a visual display
disposed within or as part of housing 200 and a visual display
disposed remotely from housing 200.
[0034] With reference now to FIG. 3, an exemplary process 300 for
documenting myocardial ischemia of a patient's heart generally
includes the steps of monitoring and collecting ECG data (step
302), receiving cardiac marker test results (step 314) and
displaying a patient report (step 322). In an exemplary embodiment
of the present invention, the various steps of process 300 may be
implemented with computer-executable instructions that are stored
in digital memory 18 and that are appropriately executed by
processor 14 (FIG. 1), or by any other processor associated with
apparatus 10.
[0035] Process 300 suitably begins by monitoring and collecting ECG
data (step 302) of a patient when a user of apparatus 10 initiates
ECG monitoring. A user may initiate ECG monitoring in any suitable
manner, such as by selecting or activating an ECG function key of
user interface 204 (FIG. 2), or by coupling the patient to
apparatus 10 using suitable ECG sensor lead wires. Process 300 also
may include the monitoring and collecting of data regarding other
patient physiological parameters. As described above, such patient
parameters may include, but are not limited to, the patient's heart
rate, the oxygen saturation of the patient's hemoglobin, the
arterial and/or venous blood pressure of the patient, and the
end-tidal carbon dioxide of the patient. Data may be collected
according to any scheme, but in an exemplary embodiment data
measurements are taken at regular intervals with a sufficiently
high frequency so that the data may facilitate diagnosis of
myocardial ischemia (e.g., on the order of every few minutes or
seconds). After the data is obtained, it is formatted or otherwise
processed as appropriate to put the data into a format that can be
readily received and processed by processor 14 (FIG. 1) or another
appropriate component of apparatus 10.
[0036] Upon receipt of the ECG data, processor 14 may cause the ECG
data to be stored in memory 18 and/or displayed, such as on patient
data display 24. Alternatively, in the embodiment shown in FIG. 3,
the ECG data collected by ECG monitor and data collector module 12
is suitably processed and interpreted to determine if it is
suggestive of myocardial ischemia (step 304). If myocardial
ischemia is determined to be present in the patient's heart, in one
exemplary embodiment of the invention, the ECG data may be
displayed in a patient report, such as on visual display 202 (FIG.
2) or in a printed patient report (step 306). In another exemplary
embodiment of the invention, a notification that myocardial
ischemia is detected may also be displayed. In a further exemplary
embodiment of the invention, the severity of the myocardial
ischemia may be analyzed by apparatus 10 and a suggested treatment
based on the determined severity may be displayed.
[0037] In one embodiment of the invention, if myocardial ischemia
is suggested by the ECG data but cannot be definitively determined,
apparatus 10 may issue a prompt for the performance of a cardiac
marker test (step 308). In an alternative embodiment of the
invention, apparatus 10 may issue a prompt for the performance of a
cardiac marker test regardless of the ECG data. The prompt may be
issued in any suitable manner, such as via an audible signal to the
user or on visual display 202 (FIG. 2).
[0038] In another, optional, embodiment of the invention, apparatus
10 may monitor a preset time period during which a cardiac marker
test is to be conducted (step 310). The preset time period may be
programmed by the user of apparatus 10 or, alternatively, may be a
pre-programmed time period. Apparatus 10 may begin monitoring the
preset time period upon issuing instructions to a user to conduct a
cardiac marker test or, alternatively, may begin monitoring the
preset time period upon activation by the user of a key, such as a
cardiac marker function key, button or other device that signals to
apparatus 10 that the user is commencing a cardiac marker test.
Apparatus 10 may monitor the preset time period using any suitable
method or device, such as a clock or timer.
[0039] Apparatus 10 then may request a user to enter the results of
the cardiac marker test (step 312). Apparatus 10 may request the
results after it has determined that the preset time period
described above has passed or, alternatively, may request the
results upon selection or activation by a user of a cardiac marker
function key of user interface 204. The results may be entered
using any suitable data input device or mechanism, such as, for
example, a keypad or touch screen, of user interface 204 used for
entering cardiac marker test results into cardiac marker data
collector 22. The results of the cardiac marker test are received
by cardiac marker data collector 22 (step 314), and the data is
formatted or otherwise processed as appropriate to put the data
into a format that can be readily received and processed by
processor 14 or another appropriate component of apparatus 10. The
data then may be transferred by processor 14 or another appropriate
component of apparatus 10 to memory 18 for later incorporation into
a patient report or to patient data display 24. In addition to the
cardiac marker test results, apparatus 10 may record the date and
time that the cardiac marker test results were received.
[0040] In another exemplary embodiment of the invention, processor
14 or another appropriate component of apparatus 10 may process the
ECG data and the results of the cardiac marker test to determine if
myocardial ischemia is present (step 318). If apparatus 10
concludes that no myocardial ischemia is present, apparatus 10 may
so notify the user (step 324) or, alternatively, may instruct the
user to continue with monitoring of the patient's ECG waveform
and/or conduct an additional cardiac marker test. If apparatus 10
concludes that myocardial ischemia is present, apparatus 10 may so
notify the user (step 320). In another embodiment of the invention,
apparatus 10 may notify the user of the indication of myocardial
ischemia and may suggest a treatment to the user (steps 320 and
322). In a further embodiment of the invention, apparatus 10 may
provide a patient report that discloses the ECG data, the results
of the cardiac marker test, any other patient parameter data, the
suggestion of myocardial ischemia, and/or any suggested treatment.
The patient report may be displayed on a visual display, such as
visual display 202, or may be printed on a printer located within
or remotely from apparatus 10.
[0041] Accordingly, there is provided apparatus and methods for
documenting myocardial ischemia in patients. An apparatus is
provided that is capable of documenting myocardial ischemia in a
patient using, for example, electrocardial waveform data. The
apparatus is further able to receive results of cardiac marker
tests performed on the patient and to document the results. The
apparatus then may provide the ECG data and the cardiac marker test
results to the user of the apparatus or a physician, clinician or
other technician for review and analysis so that the condition may
be diagnosed and treated.
[0042] While at least one exemplary embodiment has been presented
in the foregoing detailed description of the invention, it should
be appreciated that a vast number of variations exist. It should
also be appreciated that the exemplary embodiment or exemplary
embodiments are only examples, and are not intended to limit the
scope, applicability, or configuration of the invention in any way.
Rather, the foregoing detailed description will provide those
skilled in the art with a convenient road map for implementing an
exemplary embodiment of the invention. It being understood that
various changes may be made in the function and arrangement of
elements described in an exemplary embodiment without departing
from the scope of the invention as set forth in the appended
claims.
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